Chef principal, Affaires réglementaires
Core
Leading and supervising a regulatory affairs team to support the submission and approval of regulatory submissions to Health Canada for AbbVie's developing and marketed products, including medical devices.
Role type
Principal regulatory affairs leader (senior IC with team management)
Builds
Regulatory submissions and approvals for pharmaceutical and medical device products
Domain
Pharmaceutical industry, regulatory affairs, Health Canada
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, team supervision, regulatory submission preparation, stakeholder management, negotiation, networking, compliance with Health Canada policies
Preferred skills
Expertise in biologics, small molecules, medical devices, quality-related changes, clinical trial requests
Technologies
Global data management systems, Health Canada submission portals
Responsibilities
Prepare and strategically support regulatory submission activities (INDs, NDA, supplements, mandatory variations, medical device submissions); ensure submission and approval deadlines are met; supervise and mentor direct reports; conduct annual performance reviews; review submission documents for compliance with Health Canada requirements and the Food and Drugs Act; consult with global regulatory teams; support brand team meetings and new product launch reviews; manage regulatory activities related to licensing, sales, and acquisitions; support special access program requests and facility licensing requests; stay updated on Canadian Food and Drugs Act revisions; support internal and external inspections; inform leadership of regulatory activities impacting submission outcomes.
Seniority
Principal, hands-on IC with team management
